MOUNJARO (tirzepatide)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Family history of medullary thyroid carcinoma
Medullary thyroid carcinoma
Multiple endocrine neoplasia type 2

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Gastroparesis
Pancreatitis

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Dehydration
Diabetic retinopathy
Gallbladder disease
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 9 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Acute kidney injury Acute pancreatitis Anaphylaxis Angioedema Biliary calculus Dehydration Gallbladder disease Hypersensitivity drug reaction Ileus

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anorexia Constipation Diarrhea Dyspepsia Nausea Vomiting	Abdominal distension Alopecia Dizziness Elevated serum amylase Elevated serum lipase Eructation Fatigue Flatulence Gastroesophageal reflux disease Injection site sequelae

Rare/Very Rare
Dysgeusia Eczema Hypoglycemic disorder Hypotension Tachycardia Urticaria Weight loss

Available data with tirzepatide use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities (including external, visceral, and skeletal malformations) occurred at clinically relevant exposures based on AUC.

In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. Tirzepatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

There are no data on the presence of tirzepatide in animal or human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tirzepatide and any potential adverse effects on the breast-fed infant from tirzepatide or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients. In clinical trials of tirzepatide for diabetes mellitus, 30.1% of tirzepatide-treated patients were >=65 years of age and 4.1%

were >=75 years of age. In clinical trials of tirzepatide for chronic weight management, 9% of tirzepatide-treated patients were >=65 years of age and 0.5% were >=75 years of age. No overall differences in safety or efficacy have been observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.